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Contrast-Enhanced Ultrasound for Abdominal Injuries

Phase 4

Recruiting

Led By Aaron E Chen, MD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of or suspicion for blunt abdominal trauma

Hemodynamically stable (defined as not needing massive transfusion protocol and not undergoing an emergent surgical procedure within the next hour)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, which is expected to take around 3 years

Awards & highlights

Study Summary

This trial studied whether contrast enhanced ultrasound (CEUS) could replace CT scans in children with blunt abdominal trauma. CEUS didn't detect as many injuries as CT, so it's not ready to replace CT yet.

Who is the study for?

This trial is for children who may have internal injuries from blunt force to the belly. They must be stable enough not to need immediate surgery or a massive blood transfusion, and they should already be scheduled for or have had a CT scan. Kids with allergies to Lumason ingredients, heart disease, or penetrating abdominal wounds can't join.Check my eligibility

What is being tested?

The study is testing if contrast-enhanced ultrasound using LUMASON can spot internal organ damage in kids with belly injuries as an alternative to CT scans. This could avoid radiation exposure and be done right at the bedside without moving the child.See study design

What are the potential side effects?

LUMASON might cause allergic reactions in some children. Since it's used during an ultrasound, there are no radiation risks like those associated with CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had or might have had a blunt injury to my abdomen.

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I am not in need of an emergency blood transfusion or surgery within the next hour.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, which is expected to take around 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, which is expected to take around 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, which is expected to take around 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity of CEUS

Specificity of CEUS

Trial Design

1Treatment groups

Experimental Treatment

Group I: Contrast-enhanced ultrasound armExperimental Treatment2 Interventions

contrast-enhanced ultrasound

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,580,913 Total Patients Enrolled

Aaron E Chen, MDPrincipal InvestigatorChildren's Hospital of Philadelphia

2 Previous Clinical Trials

328 Total Patients Enrolled

Media Library

contrast-enhanced ultrasound Clinical Trial Eligibility Overview. Trial Name: NCT03490929 — Phase 4

Traumatic Abdomen Research Study Groups: Contrast-enhanced ultrasound arm

Traumatic Abdomen Clinical Trial 2023: contrast-enhanced ultrasound Highlights & Side Effects. Trial Name: NCT03490929 — Phase 4

contrast-enhanced ultrasound 2023 Treatment Timeline for Medical Study. Trial Name: NCT03490929 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an estimate of the participant count in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, the trial that was published on June 1st 2018 is actively seeking participants and has recently been updated on August 15th 2022. The research team needs 146 individuals across one site for this experiment."

Answered by AI

Is contrast-enhanced ultrasound sanctioned by the U.S. Federal Drug Administration?

"The risk associated with contrast-enhanced ultrasound is deemed to be low, hence the score of 3. This rating was given because this treatment has already been approved for use in clinical trials."

Answered by AI

What criteria must one fulfill to be eligible for this research program?

"This clinical study is approving the enrollment of 146 minors aged 0 and 17 suffering from abdominal injury. To be eligible, applicants must possess sufficient hemodynamic stability that excludes them from receiving massive transfusion protocol or requiring urgent surgical procedures within an hour as well as a history of blunt force trauma to their abdomen."

Answered by AI

Are there any existing research results regarding the utilization of contrast-enhanced ultrasound?

"Presently, 14 studies are being conducted in regard to contrast-enhanced ultrasonography. Of these trials, two have advanced to Phase 3. Predominantly situated in Philadelphia, Pennsylvania, there are 18 distinct test locations for this intervention."

Answered by AI

Does this research include participants aged 80 or above?

"In accordance with the prerequisites for this study, no participant may be younger than 0 or older than 17."

Answered by AI

Does this research endeavor represent a pioneering exploration into the field?

"Research into contrast-enhanced ultrasound commenced in 2017 with an initial clinical trial supported by Bracco Diagnostics, Inc. This eventful study involved 125 patients and led to the drug receiving Phase I approval. Currently, there are 14 live studies regarding this technology being conducted across 10 cities and 3 countries."

Answered by AI

Is recruitment for this experiment still open?

"Affirmative. According to clinicaltrials.gov, this particular trial is currently recruiting and was originally listed on June 1st 2018 with the most recent update occurring on August 15th 2022 seeking to enlist 146 individuals across a single site."

Answered by AI

Recent research and studies

The British Journal of RadiologyJournal

Contrast-enhanced Ultrasound (CEUS) in Blunt Abdominal Trauma

Miele, Vittorio, Claudia Lucia Piccolo, Michele Galluzzo, Stefania Ianniello, Barbara Sessa, and Margherita Trinci. 2016. “Contrast-enhanced Ultrasound (CEUS) in Blunt Abdominal Trauma”. The British Journal of Radiology. British Institute of Radiology. doi:10.1259/bjr.20150823.

Pediatric RadiologyJournal

Safety of Contrast-enhanced Ultrasound in Children for Non-cardiac Applications: A Review by the Society for Pediatric Radiology (SPR) and the International Contrast Ultrasound Society (ICUS)

Darge, Kassa, Frederica Papadopoulou, Aikaterini Ntoulia, Dorothy I. Bulas, Brian D. Coley, Lynn A. Fordham, Harriet J. Paltiel, et al.. 2013. “Safety of Contrast-enhanced Ultrasound in Children for Non-cardiac Applications: A Review by the Society for Pediatric Radiology (SPR) and the International Contrast Ultrasound Society (ICUS)”. Pediatric Radiology. Springer Science and Business Media LLC. doi:10.1007/s00247-013-2746-6.

RadiologyJournal

Blunt Abdominal Trauma: Diagnostic Performance of Contrast-enhanced US in Children—initial Experience

Valentino, Massimo, Carla Serra, Pietro Pavlica, Antonio Maria Morselli Labate, Mario Lima, Simonetta Baroncini, and Libero Barozzi. 2008. “Blunt Abdominal Trauma: Diagnostic Performance of Contrast-enhanced US in Children—initial Experience”. Radiology. Radiological Society of North America (RSNA). doi:10.1148/radiol.2463070652.

European Journal of Emergency MedicineJournal